Cavitron Prophy-Jet Air Polishing Prophylaxis System
FDA 510(k) K130862 · Dentsply Intl., Inc.
510(k) numberK130862
Submission
- Device name
- Cavitron Prophy-Jet Air Polishing Prophylaxis System
- Applicant
- Dentsply Intl., Inc.
York, PA, US - Received
- March 28, 2013
- Decision date
- July 23, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code ELC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260773 | Varios Combi Pro2ELC · Traditional | Nakanishi, Inc. | 03/10/2026SE |
| K253254 | GBT Machine Airflow Prophylaxis MasterELC · Traditional | E.M.S Electro Medical Systems S.A | 01/28/2026SE |
| K251689 | Varios 170 Lux Scaler System (VA170LUXS10); Varios 170 Lux Scaler System (VA170LUXS11)…ELC · Traditional | Nakanishi, Inc. | 09/19/2025SE |
| K242317 | Integrated Endo System (Meet Endo-II)ELC · Traditional | Denjoy Dental Co., Ltd. | 02/13/2025SE |
| K233844 | OdneCleanELC · Traditional | Odne AG | 08/08/2024SE |
| K240707 | Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-J…ELC · Traditional | Shenzhen Micro Electric Intelligence Co., Ltd. | 07/02/2024SE |
| K240801 | BioSonic US200 Ultrasonic Scaler (60034537)ELC · Traditional | Dent4you AG | 07/01/2024SE |
| K233922 | SP Newtron Can-A; Module Newtron Can-A Emb; Support Xinetic; NWT Can Slim LED Cord G3…ELC · Traditional | Satelec - Acteon Group | 03/11/2024SE |
| K223340 | EDS Calculus Softener TURBO CRELC · Traditional | Essential Dental Systems, Inc. | 12/11/2023SE |
| K230641 | Ultrasonic Scaler TipsELC · Traditional | Guilin Refine Medical Instrument Co., Ltd. | 11/21/2023SE |
More from Guilin Refine Medical Instrument Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K140347 | Ankylos C/X Implant SystemDZE · Traditional | 08/20/2014SE |
| K123615 | Iris - High Strength Glass CeramicEIH · Traditional | 02/22/2013SE |
| K103244 | Qmix 2IN1 Endodontic Irrigating SolutionKJJ · Traditional | 02/14/2011SE |
| K093221 | Pre-Cemented Orthodontic Bracket System Extension IIDYH · Special | 10/30/2009SE |
| K083805 | Ankylos C/X Dental Implant SystemDZE · Traditional | 05/22/2009SE |
| K082198 | Durashield PlusLBH · Traditional | 10/29/2008SE |
| K072730 | Friadent Cercon and Ankylos Cercon Balance AbutmentsNHA · Traditional | 03/27/2008SE |
| K072989 | Axis SystemEFB · Traditional | 01/28/2008SE |
| K073117 | Dentin Desensitizer AgentLBH · Traditional | 12/19/2007SE |
| K070538 | XP Bond Dual Cure Universal Total Etch AdhesiveKLE · Special | 03/14/2007SE |
Questions and answers
When was Cavitron Prophy-Jet Air Polishing Prophylaxis System cleared by the FDA?
Cavitron Prophy-Jet Air Polishing Prophylaxis System (K130862) received a 510(k) decision of Substantially Equivalent on July 23, 2013, 117 days after the submission was received.
What is the product code of K130862?
The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.